search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Cost-effectiveness of IVF for unexplained or mild male subfertility in women from 38 years up. A multi-centre randomized controlled trial.


- candidate number22930
- NTR NumberNTR5484
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-okt-2015
- Secondary IDsNL42977.018.15 
- Public TitleCost-effectiveness of IVF for unexplained or mild male subfertility in women from 38 years up. A multi-centre randomized controlled trial.
- Scientific TitleCost-effectiveness of IVF for unexplained or mild male subfertility in women from 38 years up. A multi-centre randomized controlled trial
- ACRONYM
- hypothesisOur hypothesis is that 8 months IVF results in 10% higher pregnancy rates leading to a live birth compared to 8 months expectant management.
- Healt Condition(s) or Problem(s) studiedIVF, Unexplained subfertility
- Inclusion criteria- Age at least 38 and younger than 42 (women must be 38, 39, 40, or 41 at inclusion).
- Had unprotected regular intercourse during at least 12 months without conception.
- Normal regular ovulatory cycle between 26 and 34 days as confirmed by either history,
basal temperature curve, ultrasound monitoring or serum progesterone
- Tubal patency of at least one tube as established with either hysterosalpingography, contrastsonography, or diagnostic laparoscopy, or a confirmed earlier intra-uterine pregnancy (miscarriage or ongoing) not through IVF.
- Partners with normal or mildly impaired semen quality (TMSC ¡İ 3 million).
- Exclusion criteria- Age <38 or >42 at the time of inclusion
- Irregular cycle, defined as < 25 days or >34 days.
- Double sided tubal occlusion
- Poor semen quality (TMSC <3 million)
- Couples undergoing IVF combined with Pre-implantation Genetic Diagnosis
- Couples undergoing ICSI combined with TESE (testiculair spermextraction)
- Couples undergoing IVF or ICSI with donor sperm
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blinding[default]
- control[default]
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate1-jan-2017
- Target number of participants440
- InterventionsIVF treatment versus expectant management
- Primary outcomeThe primary outcome is ongoing pregnancy resulting in live birth, conceived within a period of 8 months after randomisation
- Secondary outcomeSecondary outcomes are clinical pregnancy, multiple pregnancy, miscarriage, pregnancy complications, premature birth, couples¡¯ preferences, quality of life and costs. In a cost-effectiveness analysis, we will calculate incremental costs per ongoing pregnancy conceived within a time horizon of 8 months after randomisation comparing IVF to expectant management.
- Timepointsa time horizon of 8 months after randomisation
- Trial web sitehttp://www.studies-obsgyn.nl/ivf38
- status[default]
- CONTACT FOR PUBLIC QUERIESdr. M.H. Mochtar
- CONTACT for SCIENTIFIC QUERIESMD. M.H. Mochtar
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD1-okt-2015 - 5-jan-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl